4. 5 Notable papers of 2019 Titelbild

4. 5 Notable papers of 2019

4. 5 Notable papers of 2019

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 Dr. Del Tredici reviews 5 of her favorite papers from 2019. We discuss aortic stenosis, the SGLT2 inhibitors, the safety of PPIs, and whether or not you can treat osteomyelitis with oral antibiotics.Presenter: Sonya Del Tredici, MD Host: Giselle aerni, MDProducer: Robert Stuntz, MDPAPER 1: TAVR and more TAVRTranscatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients MJ Mack, et. al. The PARTNER-3 Investigators. The New England Journal of Medicine, 380 (18): 1695-1705. May 2, 2019.Why is this paper important?More TARVs than SAVRs are performed in the US, but they are traditionally reserved for intermediate and high-risk patients. This trial aimed to evaluate TAVR in low-risk surgical patients with aortic stenosis.What is the clinical question?Population: Patients with severe calcific aortic stenosis and low surgical risk. They excluded patients with low life expectancy, bicuspid aortic valves and disqualifying anatomy. The study included mostly American men, age ~71, 28% with CAD, 30% with DM, 15% with afib.Intervention: Transfemoral TAVR with a balloon-expandable valve, along with ASA+clopidogrel.Comparison: Surgical aortic valve replacement with a bioprosthetic.Outcomes: Patients were followed for 1 year.Primary endpoint: composite of all-cause mortality, stroke, and rehospitalization related to the valve.Secondary endpoints: new-onset afib, length of stay, death (30 d and 1 yr), stroke (30 d and 1 yr), rehospitalization, overall bad outcomes.These outcomes were both clinical and physiological.Is the study valid?I think this was a well-done study, and the conclusions were valid. It was randomized, but non-blinded. They enrolled 1000 patients, which was enough to power the study. The patients were similar at baseline. They had an appropriate intention-to-treat analysis, and pretty complete outcomes data. About 10% of patients in the surgery group withdrew, deciding they didn’t want surgery. The subgroups were pre-specified.Adverse events were reported.Some limitations were that they only collected 1 year of data, and since the patients were relatively young and healthy, they have a lot more than 1 year to go. I would have preferred to see what happened to them over a longer time. It was funded by the manufacturer of the valve, which may have caused some bias as well.What are the results?The results showed that TAVR is safer, has better outcomes at 30 days, and has better outcomes at 1 year. The patients who got a TAVR had shorter length of stay, fewer operative complications, were more likely to be discharged to home. They also had less afib, stroke, major bleeding, rehospitalization, and death. The only thing that was worse for the TAVR group was incidence of new LBBB.How will this study help us in patient care?The patients in this study are similar to my patients. The outcomes were clinically relevant. The benefits were both clinically and statistically significant. And TAVR is both cheaper and easier for patients. Therefore I conclude that this paper establishes TAVR as the treatment of choice for most patients whose anatomy allows it, especially older patients unconcerned about long-term valve durability. From now on surgical risk should no longer determine who should have a TAVR. Instead we can now look at life expectancy, anticoagulation needs, and long-term valve durability.PAPER 2: Doc, I feel fine. Do I have to get my valve replaced?Early Surgery or Conservative Care for Asymptomatic Aortic Stenosis The RECOVERY Trial. D Kang, S Park, S Lee, Et. al. N Eng J Med 382 (2), 111-119, January 9th, 2020Why is this paper important?In asymptomatic patients with aortic stenosis, the ideal time for surgical intervention is not known. Because the surgery is high-risk, previous guidelines recommended only doing valve replacement on symptomatic patients. But asymptomatic patients can die from sudden death, and they can sustain irreversible myocardial damage, causing later morbidity. But now that surgical techniques have improved, perhaps the risk-benefit calculation has changed, and we should be doing valve replacement on patients before they become symptomatic.What is the clinical question?Population: Included: adults with severe AS.The demographics of the participants were Korean adults, enrolled 2010-2015, mean age 64, BMI 24, HTN 40%, high chol 40%, bicuspid aortic valve 60% (which is important because that makes TAVR not an option), degenerative valve 33%.Excluded: symptomatic AS, CHF, other valve problems, and those who were not surgical candidates.Intervention: SAVR (50% mechanical, 50% biological).Comparison: conservative care, but offered surgery if AS became symptomatic. 74% eventually got surgery.Outcomes: primary endpoint: operative mortality (w/in 30 days) or CV death within trial period (4-7 yrs)Secondary endpoint: mortality, stroke, MI, repeat AV surgery, CHF hospitalizationIs the study valid?It is randomized, not blinded, multi-center study. There were 145 ...
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